Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.

NCT04797845 | Completed

• 1 other identifier: RC31/20/0477
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

Conditions

Amyotrophic Lateral Sclerosis; Noninvasive Ventilation

Keywords

Telemonitoring; amyotrophic lateral sclerosis; noninvasive ventilation; feasibility

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction of the telemonitoring of non invasive ventilation at home assessed by CSQ-8 at the end of the study

  Consumer satisfaction questionnaire (CSQ-8), minimal score is 8 and maximal score is 32. The best score is 32, that mean that patient is satisfied.

  1 year

Secondary Outcomes (5)

• Effect of remote monitoring

  every 3 months during 1 year

• Patient satisfaction during the study

  every 3 months during 1 year

• Feasibility for caregivers assessed by Zarit questionnaire

  every 3 months during 1 year

• Feasibility for caregivers assessed by Depression Anxiety Stress Scales (DASS-21) questionnaire

  every 3 months during 1 year

• Feasibility for nursing staff

  every 3 months during 1 year

Study Arms (1)

telemonitoring of non invasive ventilation at home

EXPERIMENTAL

Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

Other: teleconsultation

Interventions

teleconsultation OTHER

Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.

telemonitoring of non invasive ventilation at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years,
• Patient with Amyotrophic Lateral Sclerosis (ALS),
• Already fitted by Non Invasive Ventilation (NIV),
• Patient having signed the informed consent
• Patient affiliated to a social security scheme,
• Patient with a correct understanding of the French language,
• Patient with access to an internet connection at home.
• For the caregiver:
• Adult person
• Be the patient's primary caregiver
• Have signed the informed consent intended for the caregiver

You may not qualify if:

• Patient with another cause of chronic respiratory failure: other neuromuscular diseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease,
• Patient under guardianship or under judicial protection,
• Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Sandrine Pontier-Marchandise, MD

  University Hopsital Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 15, 2021
• Study Start: April 12, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)